EP2345414B1 - Tacrolimus preparation for external applications - Google Patents

Tacrolimus preparation for external applications Download PDF

Info

Publication number
EP2345414B1
EP2345414B1 EP09819218.0A EP09819218A EP2345414B1 EP 2345414 B1 EP2345414 B1 EP 2345414B1 EP 09819218 A EP09819218 A EP 09819218A EP 2345414 B1 EP2345414 B1 EP 2345414B1
Authority
EP
European Patent Office
Prior art keywords
tacrolimus
base
triacetin
ointment
external preparation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Not-in-force
Application number
EP09819218.0A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP2345414A4 (en
EP2345414A1 (en
Inventor
Hironori Masui
Shimpei Sato
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Takata Pharmaceutical Co Ltd
Original Assignee
Takata Pharmaceutical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Takata Pharmaceutical Co Ltd filed Critical Takata Pharmaceutical Co Ltd
Publication of EP2345414A1 publication Critical patent/EP2345414A1/en
Publication of EP2345414A4 publication Critical patent/EP2345414A4/en
Application granted granted Critical
Publication of EP2345414B1 publication Critical patent/EP2345414B1/en
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/04—Antipruritics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
EP09819218.0A 2008-10-08 2009-10-07 Tacrolimus preparation for external applications Not-in-force EP2345414B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2008261987 2008-10-08
PCT/JP2009/067488 WO2010041684A1 (ja) 2008-10-08 2009-10-07 タクロリムス外用剤

Publications (3)

Publication Number Publication Date
EP2345414A1 EP2345414A1 (en) 2011-07-20
EP2345414A4 EP2345414A4 (en) 2012-02-22
EP2345414B1 true EP2345414B1 (en) 2014-06-25

Family

ID=42100633

Family Applications (1)

Application Number Title Priority Date Filing Date
EP09819218.0A Not-in-force EP2345414B1 (en) 2008-10-08 2009-10-07 Tacrolimus preparation for external applications

Country Status (7)

Country Link
US (1) US8575189B2 (ja)
EP (1) EP2345414B1 (ja)
JP (2) JP5135441B2 (ja)
CN (1) CN102176913B (ja)
CA (1) CA2738831C (ja)
ES (1) ES2478845T3 (ja)
WO (1) WO2010041684A1 (ja)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020117134A1 (en) 2018-12-04 2020-06-11 İlko İlaç Sanayi̇ Ve Ti̇caret A.Ş. Stable tacrolimus ointment formulation for topical treatment of skin conditions

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CA2738831C (en) * 2008-10-08 2016-05-24 Takata Seiyaku Co., Ltd. Tacrolimus preparation for external applications
JP2010132607A (ja) * 2008-12-05 2010-06-17 Taisho Pharm Ind Ltd アトピー性皮膚炎治療用軟膏剤
JP2010202546A (ja) * 2009-03-02 2010-09-16 Taisho Pharm Ind Ltd アトピー性皮膚炎の治療用軟膏製剤
DE102012207989A1 (de) * 2012-05-14 2013-11-14 Beiersdorf Ag Aromatisierte Lippenbutter
CN102885761B (zh) * 2012-09-24 2015-08-05 浙江万晟药业有限公司 一种制备他克莫司软膏的方法
CN103271826B (zh) * 2013-05-15 2014-08-06 广东恒健制药有限公司 一种他克莫司软膏的工业化生产方法
CN103239391B (zh) * 2013-05-16 2015-03-18 江苏知原药业有限公司 一种他克莫司软膏
CN104127369A (zh) * 2014-07-02 2014-11-05 人福医药集团股份公司 他克莫司软膏及其制备方法
CN104612504B (zh) * 2015-01-23 2017-04-26 王宗超 一种推拉式门窗扇定位器
WO2017068673A1 (ja) * 2015-10-21 2017-04-27 マルホ株式会社 皮膚用の医薬組成物
TWI726027B (zh) * 2015-12-28 2021-05-01 日商大塚製藥股份有限公司 軟膏
CN107753419B (zh) * 2017-10-18 2020-11-03 江苏知原药业有限公司 他克莫司外用制剂
JOP20210029A1 (ar) * 2018-08-16 2021-02-14 Dr Reddys Laboratories Ltd تركيبات زيتية موضعية
CN110403902A (zh) * 2019-09-05 2019-11-05 四川明欣药业有限责任公司 一种他克莫司软膏的制备方法
CN113712900A (zh) * 2020-05-25 2021-11-30 南京帝昌医药科技有限公司 一种枸橼酸托法替布软膏组合物及其制备方法
CN112022798B (zh) * 2020-08-11 2022-04-29 四川大学华西医院 一种速效他克莫司软膏、制备方法及应用
CN114159380A (zh) * 2021-12-27 2022-03-11 卓和药业集团股份有限公司 一种他克莫司乳膏及其制备方法
CN114428133B (zh) * 2021-12-28 2023-06-09 江苏知原药业股份有限公司 一种用反相色谱法检测他克莫司软膏中杂质xv含量的方法

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US5254562A (en) * 1984-12-03 1993-10-19 Fujisawa Pharmaceutical Company, Ltd. Tricyclo compounds, a process for their production and a pharmaceutical composition containing the same
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JPH0676327B2 (ja) * 1987-04-14 1994-09-28 株式会社大塚製薬工場 ステロイド軟膏製剤
US5366971A (en) * 1987-11-09 1994-11-22 Sandoz Ltd. Use of 11,28-dioxa-4-azatricyclo[22.3.1.04,9 ]octacos-18-ene derivatives and pharmaceutical compositions containing them
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CA2738831C (en) * 2008-10-08 2016-05-24 Takata Seiyaku Co., Ltd. Tacrolimus preparation for external applications
JP2010132607A (ja) * 2008-12-05 2010-06-17 Taisho Pharm Ind Ltd アトピー性皮膚炎治療用軟膏剤
JP2010202546A (ja) * 2009-03-02 2010-09-16 Taisho Pharm Ind Ltd アトピー性皮膚炎の治療用軟膏製剤

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020117134A1 (en) 2018-12-04 2020-06-11 İlko İlaç Sanayi̇ Ve Ti̇caret A.Ş. Stable tacrolimus ointment formulation for topical treatment of skin conditions

Also Published As

Publication number Publication date
WO2010041684A1 (ja) 2010-04-15
US20110212988A1 (en) 2011-09-01
CA2738831C (en) 2016-05-24
US8575189B2 (en) 2013-11-05
EP2345414A4 (en) 2012-02-22
JP2012149097A (ja) 2012-08-09
ES2478845T3 (es) 2014-07-23
CN102176913B (zh) 2014-08-13
CN102176913A (zh) 2011-09-07
JPWO2010041684A1 (ja) 2012-03-08
CA2738831A1 (en) 2010-04-15
EP2345414A1 (en) 2011-07-20
JP5135441B2 (ja) 2013-02-06

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